FDA records indicate that there are no current recalls for this drug.
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Stannous Fluoride Recall
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Questions & Answers
Side Effects & Adverse Reactions
Pediatric patients under 12 years of age should be supervised in the use of this product. Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially in areas with high fluoride concentration in drinking water. Use in pediatric patients under age 6 requires special supervision to prevent repeated swallowing of rinse. Do not use before mixing with water. This product may produce temporary surface staining of teeth. Adequate brushing may prevent these stains which are not harmful or permanent and may be removed by your dentist. Read directions carefully before using. Keep out of reach of infants and children.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
For daily self-applied topical use as a dental caries preventive. It is well established that a 0.1% stannous fluoride rinse is a convenient way to apply fluoride to the surfaces of teeth to aid in the prevention of decalcification and dental caries. This is accomplished by increasing the resistance of tooth surfaces to acid dissolution.
History
There is currently no drug history available for this drug.
Other Information
Stannous Fluoride 0.63% Concentrate Oral Rinse is a stable, water-free concentrate containing 0.63% stannous fluoride for dilution to 0.1% stannous fluoride. This is a treatment rinse, not a mouthwash.
Active Ingredients: Stannous Fluoride 0.63% (w/w) (provides 0.1% (w/v) stannous fluoride when mixed).
Sources
Stannous Fluoride Manufacturers
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Cypress Pharmaceutical, Inc.
Stannous Fluoride | Cypress Pharmaceutical, Inc.
Adults and pediatric patients 12 years and older: use at least daily, or more often as directed, following regular brushing and flossing. Pour the concentrated rinse to the 1/8 fluid ounce mark in the mixing vial. Add water to the 1 fl. oz. mark and mix. This prepares a 0.1% (w/v) stannous fluoride rinse. Place one half of the solution into the mouth and vigorously swish for 1 minute, then expectorate. Repeat the one-minute treatment with the remaining solution and expectorate. Pediatric patients under 12 years of age: consult a dentist or physician. Pediatric patients under 12 years of age should be supervised in the use of this product. For Home Irrigators: Prepare 1 fl. oz. of rinse as described above. Pour into irrigator reservoir and add 4 more fluid ounces of water. Mix thoroughly. This prepares a 0.02% (w/v) stannous fluoride rinse. Use irrigator as directed. Rinse the irrigator with water after use.
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